Research & Development
Hoth Therapeutics submits HT-001 Investigational New Drug application to US FDA
2 December 2022 -

Hoth Therapeutics, Inc. (NASDAQ: HOTH), a US-based biopharmaceutical company, announced on Thursday that it has submitted an Investigational New Drug (IND) application to the US Food and Drug Administration for HT-001 intended to treat rash and skin disorders associated with epidermal growth factor receptor (EGFR) inhibitor therapy.

The IND Submission is being submitted via the 505(b)(2) development pathway, in which Hoth Therapeutics intends to rely on information not obtained through right of reference in order to reduce the nonclinical and clinical program and expedite time to NDA submission.

During the pre-IND meeting with the FDA, Hoth Therapeutics plans to discuss the overall proposed drug development program for HT-001 including requirements for nonclinical, clinical pharmacology, clinical, and chemistry, manufacturing, controls. Hoth also plans to present clinical trial designs for the IND-opening, phase 2a dose ranging study as well as a proposed follow-up phase 2b safety and efficacy dose extension study; both studies will be conducted in cancer patients receiving EGFR inhibitor therapy.). The FDA will review this application and determine the acceptability of the data before Hoth begins this first clinical trial, which could be as early as Q1 2023. It is possible that the FDA will require additional information.